CDERLearn Training and Education | FDA

CDERLearn Training and Education | FDA

Stability and Beyond Use Dates CE Credits; Health Care Professionals; Case Study; Podcasts; Videos; Webinars Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; MedWatch FDA D.I.S.C.O. Burst Edition: FDA approval of Tafinlar (dabrafenib) with Mekinist (trametinib) for pediatric patients with low-grade glioma with a BRAF V600E mutation Health Care Professionals; Patients; Podcasts Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety FDA approval of Verzenio (abemaciclib) Health Care Professionals; Patients; Podcasts; Women’s Health Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety FDA approval of Jemperli (dostarlimab-gxly) Health Care Professionals; Patients; Podcasts; Women’s Health Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety FDA approval of Trodelvy (sacituzumab govitecan-hziy) Health Care Professionals; Patients; Podcasts; Women’s Health Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety FDA approvals of Jaypirca (pirtobrutinib) and Orserdu (elacestrant) Health Care Professionals; Patients; Podcasts; Women’s Health Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety FDA approval of Keytruda (pembrolizumab) Health Care Professionals; Patients; Podcasts Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety FDA approvals of Tukysa (tucatinib) Health Care Professionals; Patients; Podcasts Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety Biosimilars: What Patients Need to Know Patients; Graphics Biosimilars; Diabetes; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs Biosimilars: What Patients With Diabetes Need To Know Patients; Graphics Biosimilars; Diabetes; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs Biosimilar Basics Patients; Graphics Biosimilars; Diabetes; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs Biosimilares: Lo que los pacientes deben saber Patients; Graphics Biosimilars; Diabetes; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs Biosimilares: Lo que los pacientes con diabetes deben saber Patients; Graphics Biosimilars; Diabetes; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs Conceptos básicos sobre los biosimilares Patients; Graphics Biosimilars; Diabetes; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs Biosimilar Basics for Patients Patients; Graphics Biosimilars; Diabetes; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs Airflow Health Care Professionals; Graphics; Webinars Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety Personnel Gowning in Sterile Drug Production Health Care Professionals; Graphics; Webinars Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety Insanitary Conditions and Sterility Assurance Health Care Professionals; Graphics; Webinars Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety Supplier/Contractor Qualification and Management Health Care Professionals; Graphics; Webinars Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety Investigations and Corrective and Preventive Actions (CAPA) Health Care Professionals; Graphics; Webinars Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety Outsourcing Facility Guide Health Care Professionals; Graphics; Webinars Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety Sterility Testing: Common Misconceptions Health Care Professionals; Graphics; Webinars Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety Regulatory Framework for Human Drug Compounding Health Care Professionals; Graphics; Webinars Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety Aseptic Process Simulations (Media Fills) Health Care Professionals; Graphics; Webinars Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety MedWatch, Your Report Can Make a Difference with Dr. Gerald Dal Pan Health Care Professionals; Podcasts Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch Expanded Access with Dr. Jacqueline Corrigan-Curay Health Care Professionals; Patients; Graphics Disease States; Drug Development; Drug Regulatory Process; Drug Safety; IND Are you on a biologic medication? Patients; Graphics Biosimilars; Disease States; Drug Development; Drug Regulatory Process; Drug Safety Summary Report for Biosimilars Health Care Professionals; Patients; Graphics Biosimilars; Disease States; Drug Development; Drug Regulatory Process; Drug Safety Biosimilars Multimedia Education Materials Health Care Professionals; Patients; Graphics; Podcasts; Social Media; Videos; Webinars Biosimilars; Disease States; Drug Development; Drug Regulatory Process; Drug Safety Biosimilars Overview for Health Care Professionals Health Care Professionals; Graphics; Podcasts; Videos; Webinars Biosimilars; Disease States; Drug Development; Drug Regulatory Process; Drug Safety FDA 101: An Overview of FDA’s Regulatory Review and Research Activities Health Care Professionals; Patients; Webinars Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; IND; OTC Drug Regulations; Women’s Health FDA Insight Health Care Professionals; Patients; Podcasts Compounding; COVID-19; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; Opioids; Women’s Health; OTC Drug Regulations Health Equity Forum Podcast Health Care Professionals; Patients; Podcasts COVID-19; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Diabetes; Women’s Health MedWatch, Your Report Can Make a Difference Health Care Professionals; Patients; Podcasts Drug Safety; MedWatch; Generic Drugs; Disease States; Drug Regulatory Process Pregnancy and Lactation Medication Information for the Healthcare Provider CE Credits; Health Care Professionals; Webinars; Videos; Social Media Women’s Health; Disease States; Drug Regulatory Process; Drug Safety Minority Health and Health Equity Webinars Health Care Professionals; Patients; Podcasts; Videos; Webinars Disease States; Drug Development; Drug Regulatory Process; Drug Safety Why Does the FDA Exist? Health Care Professionals; Patients; Videos; Podcasts; Social Media Disease States; Drug Development; Drug Regulatory Process; Drug Safety Achieving Data Quality and Integrity in Maximum Containment Laboratories Health Care Professionals; Patients; Webinars Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Topics in Public Health CE Credits; Health Care Professionals; Patients; Case Study; Webinars Biomarker; Biosimilars; Cancer Drugs; Compounding; COVID-19; Diabetes; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; IND; MedWatch; Opioids; OTC Drug Regulations; Women’s Health Conversations on Cancer: “What’s on the Horizon: Future of Cancer Care” Health Care Professionals; Patients; Webinars Cancer Drugs; Disease States Conversations on Cancer: “Seasons of Change: Oncology Careers” Health Care Professionals; Patients; Webinars Cancer Drugs; Disease States Application of Artificial Intelligence and Machine Learning for Precision Medicine Health Care Professionals; Patients; Webinars Disease States; Drug Development; Drug Regulatory Process; Drug Safety Joint US FDA – Health Canada ICH Public Meeting Health Care Professionals; Patients; Webinars Disease States; Drug Development; Drug Regulatory Process; Drug Safety; IND FDA Rare Disease Day 2023 Health Care Professionals; Patients; Webinars Biomarker; Disease States; Drug Development; Drug Regulatory Process; Drug Safety Risk Evaluation and Mitigation Strategies (REMS) Program Part 1 Health Care Professionals; Patients; Graphics Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs Risk Evaluation and Mitigation Strategies (REMS) Program Part 2 Health Care Professionals; Patients; Graphics Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs International 2022 Drug-Induced Kidney Injury Biomarker Workshop Day 1 and Day 2 Health Care Professionals; Patients; Videos Biomarker; Disease States; Drug Development; Drug Regulatory Process Advancing Regulatory Science at FDA Health Care Professionals; Patients; Graphics Biomarker; Disease States; Drug Development; Drug Regulatory Process Accelerating Access to Critical Therapies for ALS Health Care Professionals; Patients; Graphics; Videos Biomarker; Disease States; Drug Development; Drug Regulatory Process Accelerating Rare disease Cures (ARC) Program Health Care Professionals; Patients; Videos Biomarker; Disease States; Drug Development; Drug Regulatory Process Successes and Opportunities in Modeling and Simulation for FDA Health Care Professionals; Patients; Graphics Biomarker; Disease States; Drug Development; Drug Regulatory Process FDA’s Work to Combat the COVID-19 Pandemic Health Care Professionals; Patients; Graphics COVID-19; Disease States; Drug Development; Drug Regulatory Process; Drug Safety Working with patient advocacy groups Health Care Professionals; Patients; Podcasts Biomarker; Disease States; Drug Development; Drug Regulatory Process; Drug Safety Drug compounding Health Care Professionals; Patients; Podcasts Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety Talking translational science Health Care Professionals; Patients; Podcasts Biomarker; Disease States; Drug Development; Drug Regulatory Process; Drug Safety Addressing the Opioid Epidemic Health Care Professionals; Patients; Podcasts Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch; Opioids Antibiotic Misuse and Resistance Health Care Professionals; Patients; Podcasts Disease States; Drug Safety; MedWatch FDA’s Adverse Event Reporting System (FAERS) Health Care Professionals; Patients; Podcasts Drug Safety; MedWatch; Generic Drugs Breakthrough Therapy Designation Health Care Professionals; Patients; Podcasts Disease States; Drug Development; Drug Regulatory Process; Drug Safety Biosimilars: Are they the same quality? Health Care Professionals; Patients; Graphics Biosimilars; Disease States; Drug Regulatory Process; Drug Development; Drug Safety How to Use the Consumer Complaint System and MedWatch Health Care Professionals; Patients Drug Safety; MedWatch Reporting Unlawful Sales of Medical Products on the Internet Health Care Professionals; Patients Drug Safety Health Fraud Product Database Health Care Professionals; Patients Drug Safety Compounding Outsourcing Facilities Annual Study Health Care Professionals; Patients; Webinars Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety Compounding Quality Center of Excellence Virtual Conference Health Care Professionals; Patients; Webinars Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety State of Outsourcing Facility Sector and Possibilities for the Future Health Care Professionals; Patients; Webinars Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety Areas of Customer Need for Outsourcing Facility Products Health Care Professionals; Patients; Webinars Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety Compounding Quality Center of Excellence Cross-Sector Health Care Professionals; Patients; Webinars Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety Compounding Quality Center of Excellence Virtual Live Training  CE Credits; Health Care Professionals; Case Study; Podcasts; Videos; Webinars Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; MedWatch Equity of Voices video series Health Care Professionals; Patients; Case Study; Podcasts; Videos; Webinars Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch Biosimilars in the Real World: Perspectives for Staying Within the Scope of Care CE Credits; Health Care Professionals; Case Study; Podcasts; Videos; Webinars Biosimilars; Cancer Drugs; Diabetes; Disease States; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; MedWatch Pregnancy and Lactation Medication Information for the Healthcare Provider: Health Care Professionals; Patients; Webinars Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch; Women’s Health Leveraging Real-World Data to Study Medication Use in Pregnancy and Lactation Health Care Professionals; Patients; Webinars Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch; Women’s Health CBD and Other Cannabinoids: Sex and Gender Differences in Use and Responses Health Care Professionals; Patients; Webinars Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch; Opioids; Women’s Health Opioid and Nicotine Use, Dependence, and Recovery: Influences of Sex and Gender Health Care Professionals; Patients; Webinars Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch; Opioids; Women’s Health Maximizing Benefits and Minimizing Harms from Antibiotics Health Care Professionals; Patients; Webinars Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch Health Fraud Scams Health Care Professionals; Patients; Webinars Drug Safety 6 Tip-Offs to Rip-Offs: Don’t Fall for Health Fraud Scams Health Care Professionals; Patients; Webinars Drug Safety BeSafeRx: Your Source for Online Pharmacy Information Health Care Professionals; Patients; Webinars Drug Safety

COVID-19 Health Care Professional Resources

Health Care Professionals; Patients; Podcasts; Videos COVID-19; Disease States; Drug Regulatory Process; Drug Development; Drug Safety; MedWatch FDA’s Overdose Prevention Framework with Dr. Marta Sokolowska Health Care Professionals; Patients; Podcasts Disease States; Drug Regulatory Process; Drug Development; Drug Safety; MedWatch; Opioids; Cancer Drugs FDA Health Playbook Health Care Professionals; Patients; Videos; Graphics; Podcasts; Social Media Drug Safety; OTC Drug Regulations; MedWatch; Opioids 14th Annual Sentinel Initiative Public Workshop Health Care Professionals; Patients; Webinars COVID-19; Disease States; Drug Regulatory Process; Drug Development; Drug Safety Medical Extended Reality: Applications and Challenges Health Care Professionals; Patients; Webinars Disease States; Drug Regulatory Process; Drug Development; Drug Safety

Highlights in Oncofertility: Trends in an Emerging Field for Cancer Survivors

Health Care Professionals; Patients; Webinars Cancer Drugs; Disease States; Drug Regulatory Process; Drug Development; Drug Safety; Women’s Health What does FDA regulate? Health Care Professionals; Patients; Videos; Graphics Disease States; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; OTC Drug Regulations; Women’s Health FDA Grand Rounds Health Care Professionals; Patients; Webinars COVID-19; Disease States; Drug Regulatory Process; Drug Development; Drug Safety; MedWatch; Generic Drugs; OTC Drug Regulations; Biosimilars; IND; Cancer Drugs; Biomarker; Women’s Health Safe Opioid Disposal Safe Opioid Disposal – Remove the Risk Outreach Toolkit Disease States; Drug Regulatory Process; Drug Development; Drug Safety; MedWatch; Generic Drugs; Cancer Drugs; Opioids What Does FDA Do? Health Care Professionals; Patients; Videos Disease States; Drug Regulatory Process; Drug Development; Drug Safety; MedWatch; Generic Drugs; OTC Drug Regulations; IND; Women’s Health Conversation on Paxlovid with Dr. John Farley Health Care Professionals; Patients; Podcasts COVID-19; Disease States; Drug Regulatory Process; Drug Development; Drug Safety Clinical Trial Basics with Dr. Robert Temple Health Care Professionals; Patients; Podcasts Disease States; Drug Regulatory Process; Drug Development; Drug Safety; IND; Biomarker; Women’s Health Biosimilars Patient Materials Graphics; Videos; Patients Biosimilars; Drug Regulatory Process; Drug Development; Disease States; Drug Safety Clinical Trial Basics Health Care Professionals; Podcasts Biomarkers; Disease States; Drug Regulatory Process; Drug Development; Drug Safety; IND; Women’s Health Adverse Events Associated with Compounded Drugs from Outsourcing Facilities Health Care Professionals; Case Study; Podcasts; Videos; Webinars Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; MedWatch Biosimilars 101: A Primer for Your Practice CE Credits; Health Care Professionals; Case Study Biosimilars; Cancer Drugs; Diabetes; Disease States; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; MedWatch; Women’s Health Incorporating Biosimilars Into the Management of Patients With Immunological Conditions CE Credits; Health Care Professionals; Case Study Biosimilars; Cancer Drugs; Diabetes; Disease States; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; MedWatch; Women’s Health Putting the Patient into Perspective: Strategies for Educating Patients about Biosimilars CE Credits; Health Care Professionals; Case Study; Podcasts; Videos; Webinars Biosimilars; Cancer Drugs; Diabetes; Disease States; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; MedWatch; Women’s Health Biosimilars Resources Health Care Professionals; Case Study; Podcasts; Videos; Webinars Biosimilars; Drug Regulatory Process; Drug Development Bridging Efficacy and Safety to the Obese Health Care Professionals; Webinars Biomarker; Cancer Drugs; Diabetes; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; IND; MedWatch; Women’s Health Engaging Providers to Address Knowledge Gaps on Medication Use in Pregnancy and Lactation CE Credits; Health Care Professionals; Webinars Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch; Women’s Health Biosimilars Videos Healthcare Professionals; Videos Biosimilars; Drug Regulatory Process Drug Development Biosimilars Level 2: Regulatory and Scientific Concepts Case Study Health Care Professionals Biosimilars Level 1: Foundational Concepts Case Study Health Care Professionals Increasing the Efficiency of Biosimilar Development Programs Health Care Professionals; Webinars Biosimilars; Drug Regulatory Process; Drug Development Successfully Navigating the USPTO and FDA CE Credits; Webinars Drug Development; Drug Regulatory Process; Drug Safety; Registration and Listing The History of FDA Health Care Professionals; Webinars Drug Development; Drug Regulatory Process; Drug Safety Bench to Bedside: Integrating Sex and Gender to Improve Human Health CE Credits; Health Care Professionals; Webinars Diabetes; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Women’s Health Q&A with FDA Health Care Professionals; Podcasts COVID-19; Disease States; Drug Regulatory Process; Drug Development; Drug Safety; MedWatch Biosimilars Level 1: Foundational Concepts Health Care Professionals; Case Study Biosimilars; Drug Regulatory Process; Drug Development Biosimilars Level 2: Regulatory and Scientific Concepts Health Care Professionals; Case Study Biosimilars; Drug Regulatory Process; Drug Development Biosimilars Curriculum Materials Health Care Professionals; Case Study; Podcasts; Videos; Webinars Biosimilars; Drug Regulatory Process; Drug Development Drug Approval Case Studies Case Study; Health Care Professionals; Patients; Graphics Diabetes; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; IND FDA’s Role in Public Health: Drug Efficacy, Safety, Quality, and Beyond Health Care Professionals; CE Credits Drug Regulatory Process Practitioners’ Guide for Improving Oral Anticoagulant Use Health Care Professionals; CE Credits Oral Anticoagulant; Disease States The FDA Bad Ad Program and Prescription Drug Promotion Health Care Professionals; CE Credits Prescription Drug Promotion FDA MedWatch and Patient Safety Health Care Professionals MedWatch; Drug Safety The FDA Process for Approving Generic Drugs Health Care Professionals Drug Regulatory Process; Drug Development; Generic Drugs FDA Overview of Biosimilar Products Health Care Professionals; Videos Biosimilars; Drug Regulatory Process; Drug Development Leveraging Health Literacy and Patient Preferences to Reduce Hypoglycemia Events in Patients with Type 2 Diabetes Health Care Professionals Diabetes; Disease States Director’s Corner Podcasts Health Care Professionals; Podcasts Drug Regulatory Process; Drug Development; Compounding; Generic Drugs; Drug Safety; MedWatch; Disease States Drug Information Soundcast in Clinical Oncology (D.I.S.C.O) Health Care Professionals; Podcasts Cancer Drugs; Disease States; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; MedWatch; Women’s Health FDA Drug Safety Podcasts Health Care Professionals; Podcasts Drug Safety; Biosimilars; Cancer Drugs; Diabetes; Disease States; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; MedWatch; Women’s Health Regulatory Science at CDER Podcasts Health Care Professionals; Podcasts Drug Development; Disease States; Drug Regulatory Process; Drug Safety; IND FDA’s Biomarker Qualification Program Videos Biomarker; Drug Development Biosimillars Health Care Provider Materials Health Care Professionals; Videos; Graphics; Social Media Biosimilars; Drug Regulatory Process; Drug Development; Disease States; Drug Safety FDA Drug Info Rounds Health Care Professionals; Videos Drug Safety; MedWatch; IND; Drug Development; Drug Regulatory Process; Prescription Drug Promotion; Disease States; Registration and Listing; Generic Drugs GDUFA II Videos and Resources Videos Drug Development; Generic Drugs Regulatory Science at CDER Videos Videos Drug Regulatory Process; Drug Development Biosimilars Online Courses, Webinars, and Presentations Health Care Professionals; Webinars Biosimliars; Drug Regulatory Process; Drug Development CDER Webinars Health Care Professionals; Webinars Drug Regulatory Process; Drug Development; Generic Drugs; OTC Drug Regulations; Registration and Listing; Electronic Submissions; Biosimilars; Drug Safety; MedWatch; IND; Disease States; Prescription Drug Promotion; Cancer Drugs Division of Drug Information Webinars Health Care Professionals; Webinars; CE Credits Drug Regulatory Process; Drug Development; Generic Drugs; OTC Drug Regulations; Biosimilars; Drug Safety; MedWatch; IND; Disease States; Prescription Drug Promotion; Cancer Drugs Compounding Quality Center of Excellence On-Demand Training CE Credits; Health Care Professionals; Case Study; Podcasts; Videos; Webinars Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; MedWatch